Aqueous extraction contains ≤0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) Test
Bacterial Retention
Samples were quantitatively retentive of a minimum Brevundimonas diminuta challenge concentration of 1 x 10⁷ CFU/cm² using ASTM® F838 methodology.
Cartridge Code
Not Applicable
Cartridge Nominal Length
1 in. (2.5 cm)
Catalogue Number
LAGRM1S02
Chemistry
Polytetrafluoroethylene (PTFE)
Device Configuration
Cartridge
Device Material
Polypropylene
Device Size
1 in.
Filtration Area
0.05 m²
Good Manufacturing Practices
These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Gravimetric Extractables
The extractables level was equal to or less than 10 mg per 4-inch cartridge after 24 hours in a 70/30% IPA/water mixture at controlled room temperature.
Indirect Food Additive
All component materials meet the FDA Indirect Food Additive requirements cited in 21 CFR 177-182.
Length
1 in. (2.5 cm)
Material Package
Double Easy-Open bag
Material Size
2
Maximum Differential Pressure, bar (psid)
Forward: 5.5 bar (80 psid) @ 25 °C; 1.7 bar (25 psid) @ 80 °C; 0.35 bar (5 psid) @ 135 °C. Reverse: 4.1 bar (60 psid)
Maximum Inlet Pressure, bar (psi)
Forward - 5.5 bar (80 psi) @ 25 °C; 1.7 bar (25 psi) @ 80 °C; 0.35 bar (5 psi) @ 135 °C; Reverse - 4.1 bar (60 psi)
Media
Aervent®
Non-Fiber Releasing
This product was manufactured with a PTFE membrane which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).
Pore Size
0.2 µm
Seal Material
Silicone (SI)
Sterilization
80 (40 forward/40 reverse) SIP cycles of 30 min @ 135 °C
Support Material
Polypropylene
Trade Name
Optiseal®
USP Bacterial Endotoxins
A sample aqueous extraction contains less than 0.5 EU/mL as determined by the Limulus Amebocyte Lysate (LAL) test.
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